Ignite Creation Date:
2025-12-25 @ 4:35 AM
Ignite Modification Date:
2026-01-10 @ 1:27 AM
Study NCT ID:
NCT05413018
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-08
First Post:
2022-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Efficacy and Safety Study of Oral Azacitidine (CC-486) as Maintenance Therapy in Chinese Participants With Acute Myeloid Leukemia in Complete Remission
Sponsor:
Organization:
Raw JSON
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HRU is a key component to understand treatment costs and budget impact of new treatments from a provider perspective.'}, {'measure': 'Healthcare Resource Utilization (HRU): Number of Medications', 'timeFrame': 'Up to approximately 30 months', 'description': 'HRU is defined as any consumption of healthcare resources directly or indirectly related to the treatment of the participant. HRU is a key component to understand treatment costs and budget impact of new treatments from a provider perspective.'}, {'measure': 'Healthcare Resource Utilization (HRU): Rate of Clinic Visits Per Year', 'timeFrame': 'Up to approximately 30 months', 'description': 'HRU is defined as any consumption of healthcare resources directly or indirectly related to the treatment of the participant. HRU is a key component to understand treatment costs and budget impact of new treatments from a provider perspective.'}, {'measure': 'Healthcare Resource Utilization (HRU): Rate of Medical/Diagnostic Events Per Year', 'timeFrame': 'Up to approximately 30 months', 'description': 'HRU is defined as any consumption of healthcare resources directly or indirectly related to the treatment of the participant. HRU is a key component to understand treatment costs and budget impact of new treatments from a provider perspective.'}, {'measure': 'Healthcare Resource Utilization (HRU): Number of Treatments for AEs Per Year', 'timeFrame': 'Up to approximately 30 months', 'description': 'HRU is defined as any consumption of healthcare resources directly or indirectly related to the treatment of the participant. HRU is a key component to understand treatment costs and budget impact of new treatments from a provider perspective.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Azacitidine', 'CC-486', 'Onureg', 'Acute Myeloid Leukemia'], 'conditions': ['Leukemia, Myeloid, Acute']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of Oral Azacitidine (CC-486) in Chinese participants with acute myeloid leukemia in complete remission.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed, histologically confirmed de novo acute myeloid leukemia (AML) or AML secondary to prior myelodysplastic disease or chronic myelomonocytic leukemia (CMML)\n* Eastern cooperative oncology group performance status of 0, 1, or 2\n* Has undergone induction therapy with intensive chemotherapy with or without consolidation therapy\n* Must have achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) status within 6 months (+/- 7 days) prior to starting study therapy\n\nExclusion Criteria:\n\n* Suspected or proven acute promyelocytic leukemia or acute myeloid leukemia with previous hematologic disorder such as chronic myeloid leukemia or myeloproliferative neoplasms, excluding myelodysplastic syndromes and chronic myelomonocytic leukemia\n* Candidate for allogeneic bone marrow or stem cell transplant at screening\n* Have achieved CR/CRi following therapy with hypomethylating agents\n* AML associated with inv(16), t(8;21), t(16;16), t(15;17), or t(9;22) karyotypes or molecular evidence of such translocations\n* Proven central nervous system leukemia\n* Prior bone marrow or stem cell transplantation\n\nOther protocol-defined inclusion/exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT05413018', 'briefTitle': 'An Efficacy and Safety Study of Oral Azacitidine (CC-486) as Maintenance Therapy in Chinese Participants With Acute Myeloid Leukemia in Complete Remission', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Compare Efficacy and Safety of Oral Azacitidine (CC-486) Plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Chinese Patients With Acute Myeloid Leukemia in Complete Remission', 'orgStudyIdInfo': {'id': 'CA055-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CC-486/Oral Azacitidine Administration', 'interventionNames': ['Drug: CC-486']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Administration', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'CC-486', 'type': 'DRUG', 'otherNames': ['Azacitidine', 'Onureg'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['CC-486/Oral Azacitidine Administration']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Placebo Administration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '230001', 'city': 'Hefei', 'state': 'Anhui', 'country': 'China', 'facility': 'Local Institution - 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